Drug utilization and off-label drug use among Spanish emergency room paediatric patients

European Journal of Clinical Pharmacology

Volumn 66, Issue 3, 2010, Pages 315-320

  Morales Carpi, Cristina ^a,b   Estañ, Luis ^c   Rubio, Elena ^b,c   Lurbe, Empar ^a   Morales Olivas, Francisco J ^c  

^a Agencia Valenciana de Salud   (Spain)

^b HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA   (Spain)

^c UNIVERSITY OF VALENCIA   (Spain)

Author keywords

Children; Drug utilization study; Off label use

Indexed keywords

ACETYLSALICYLIC ACID; AMOXICILLIN; DEXTROMETHORPHAN; DOMPERIDONE; IBUPROFEN; MONTELUKAST; PARACETAMOL; SALBUTAMOL;

ADOLESCENT; ARTICLE; CHILD; CHILD CARE; COHORT ANALYSIS; CONTROLLED STUDY; DESCRIPTIVE RESEARCH; DRUG ADMINISTRATION ROUTE; DRUG CLASSIFICATION; DRUG FORMULATION; DRUG INFORMATION; DRUG UTILIZATION; EMERGENCY WARD; FEMALE; GROUPS BY AGE; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; OFF LABEL DRUG USE; PATIENT INFORMATION; PRESCRIPTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; SPAIN; TREATMENT INDICATION; AGE; CHI SQUARE DISTRIBUTION; CLINICAL PRACTICE; DRUG USE; EMERGENCY HEALTH SERVICE; PEDIATRICS; PRACTICE GUIDELINE; PRESCHOOL CHILD; STATISTICS;

ADOLESCENT; AGE FACTORS; CHI-SQUARE DISTRIBUTION; CHILD; CHILD, PRESCHOOL; DRUG UTILIZATION; DRUG UTILIZATION REVIEW; EMERGENCY SERVICE, HOSPITAL; FEMALE; GUIDELINE ADHERENCE; HUMANS; INFANT; MALE; OFF-LABEL USE; PEDIATRICS; PHYSICIAN'S PRACTICE PATTERNS; PRACTICE GUIDELINES AS TOPIC; PROSPECTIVE STUDIES; SPAIN;

EID: 77951914970     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-009-0747-z     Document Type: Article

References (25)

1. Morales-Olivas FJ, Morales-Carpi C (2006) Clinical trials in children. Rev Recent Clin Trials 1:251-258
2. Pandolfini C, Impicciatore P, Provasi D, Rocchi F, Campi R, Bonati M (2002) Off-label use of drugs in Italy: a prospective, observational and multicentre study. Acta Paediatr 91:339-347 (Pubitemid 34270876)
3. Cuzzolin L, Zaccaron A, Fanos V (2003) Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol 17:125-131
4. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A et al (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. European network for drug investigation in children. Br Med J 320:79-82
5. Turner S, Longworth A, Nunn AJ, Choonara I (1998) Unlicensed and off-label drug use in paediatric wards: prospective study. Br Med J 316:343-345
6. McIntyre J, Conroy S, Avery A, Corns H, Choonara I (2000) Unlicensed and off-label prescribing of drugs in general practice. Arch Dis Child 83:498-501
7. Pandolfini C, Bonati M (2005) A literature review on off-label drug use in children. Eur J Pediatr 164:552-558
8. Chalumeau M, Tréluyer JM, Salanave B, Assathiany R, Chéron G, Crocheton N et al (2000) Off-label and unlicensed drug used among French office based paediatricians. Arch Dis Child 83:502-505
9. Pandolfini C, Campi R, Clavenna A, Cazzato T, Bonati M (2005) Italian paediatricians and off-label prescriptions: loyal to regulatory or guideline standards? Acta Paediatr 94:753-757
10. Horen B, Montastruc JL, Lapeyre-Mestre M (2002) Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 54:665-670
11. Lifshitz M, Gavrilov V, Grossman Z, Binsthok M, Hornik D, Rosemblum H et al (2002) Unapproved prescription practices in primary pediatric clinics in Israel: a prospective analysis. Curr Ther Res Clin Exp 63:830-837
12. Bazzano AT, Mangione-Smith R, Schonlau M, Suttorp MJ, Brook RH (2009) Off-label prescribing to children in the United States outpatient setting. Acad Pediatr 9:81-88
13. Danés I, Vallano A, de la Cruz G, Juárez JC, Arnau JM (2002) Utilización de medicamentos y condiciones de uso recomendadas en pediatría. An Pediatr (Barc) 57:414-419
14. Cazzato T, Pandolfini C, Campi R, Bonati M (2001) Drug prescribing in out-patients children in Southern Italy. Eur J Clin Pharmacol 57:611-616
15. Sanz E, Hernandez MA, Ratchina S, Stratchounsky L, Peiré MA, Lapeyre-Mestre M et al (2004) Drug utilisation in outpatient children. A comparison among Tenerife, Valencia, and Barcelona (Spain), Toulouse (France), Sofia (Bulgaria), Bratislava (Slovakia) and Smolensk (Russia). Eur J Clin Pharmacol 60:127-134
16. Martínez-Mir I, García-López M, Palop V, Ferrer JM, Rubio E, Morales-Olivas FJ (1999) A prospective study of adverse drug reactions in hospitalized children. Br J Clin Pharmacol 47:681-688
17. Turner S, Nunn AJ, Choonara I (1997) Unlicensed drug use in children in the UK. Paediatr Perinatal Drug Ther 1:52-55
18. Neubert A, Wong IC, Bonifazi A, Catapano M, Felisi M, Baiardi P et al (2008) Defining off-label and unlicensed use of medicines for children: results of a Delphi survey. Pharmacol Res 58:316-322
19. McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, Fisher P (2007) The Hawthorne effect: a randomised, controlled trial. BMC Med Res Methodol 7:30
20. Ekins-Daukes S, Helms PJ, Simpson CR, Taylor MW, McLay JS (2004) Off-label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol 60:349-353
21. Headley J, Northstone K (2007) Medication administered to children from 0 to 7.5 years in the Avon Longitudinal Study of Parents and Children (ALSPAC). Eur J Clin Pharmacol 63:189-195
22. Hoppu K (2008) Paediatric clinical pharmacology-at the beginning of a new era. Eur J Clin Pharmacol 64:201-205
23. Schirm E, Tobi H, de Jong-van den Berg LT (2003) Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics 111:291-295
24. Morales-Carpi C, Estañ L, Torró I, Lurbe E, Morales-Olivas FJ (2006) ¿Son los niños hipertensos españoles huérfanos terapéuticos? An Pediatr (Barc) 64:114-119
25. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Available at: http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-1/reg-2006-1901/reg-2006-1901-en.pdf. Accessed 17 July 2009